510(k) K974609 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
REP CHOLESTEROL PROFILE CONTROL-II
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Jan 6, 1998 |
| Received | Dec 10, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974609
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.